GENERIC NAME: PROMETHAZINE/PHENYLEPHRINE/CODEINE - ORAL (pro-METH-uh-zeen/fen-ill-EFF-rin AND KO-deen)
WARNING: Children should not use products that contain codeine after certain surgeries (including tonsil/adenoid removal). Also, this medication should not be used in children younger than 6 years due to an increased risk for serious (rarely fatal) breathing problems such as slow/shallow breathing. This infrequent side effect may occur even with usual prescribed doses. The lowest effective dose should be used, and other drugs that may slow down breathing should be avoided. For children between 6 and 12 years old, do not use this product to treat cough or pain unless specifically directed by the doctor. Some manufacturers also recommend that promethazine and other drugs that may also slow down breathing (such as the codeine in this product) should not be used together in children younger than 16 years. Get medical help right away if you notice symptoms of slow/shallow breathing (See also Side Effect section). Talk with your doctor or pharmacist about the risks and benefits of this medication.
USES: See also Warning Section.This combination medication is used to treat symptoms caused by the common cold, flu, allergies, or other breathing illnesses (e.g., sinusitis, bronchitis). Promethazine is an antihistamine that relieves watery eyes, itchy eyes/nose/throat, runny nose, and sneezing. Phenylephrine is a decongestant that relieves stuffy nose symptoms. Codeine is a narcotic cough suppressant (antitussive) that affects a certain part of the brain, reducing the urge to cough.Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Therefore, this product is not recommended to treat cold symptoms in children younger than 6 years. Some products (including some long-acting tablets/capsules) are not recommended for use in children younger than 12 years. Ask your doctor or pharmacist for more details about using your product safely.These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Giving more than the recommended dose or using this medication along with other cough-and-cold products has resulted in serious (even fatal) side effects, including slowed/stopped breathing. Talk to the doctor or pharmacist before giving other cough-and-cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray). Do not use this product to make a child sleepy.
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